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    K Number
    K072463
    Device Name
    SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM
    Manufacturer
    SATYRNE MEDICAL
    Date Cleared
    2007-11-29

    (90 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    SATYRNE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Satyrne's InterFlex Mandibular Fixation System is intended for the stabilization and rigid fixation of fractures and reconstructive procedures of the mandibular skeleton. Each device is intended for single use only in conjunction with other titanium and titanium alloy implants.
    Device Description
    Satyrne InterFlex Mandibular Fixation System is a new bone plate system for use in oral and maxillofacial surgery. The design includes plates of different thicknesses that are secured to the mandibular bony tissue using bone screws of varying lengths and designs. The bone plates and bone screws will be manufactured of commercially pure (CP) titanium or Ti6Al4V alloy in compliance with ASTM F67 and ASTM F136.
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